POS0809 CHARACTERIZATION OF RELAPSES IN PATIENTS WITH GIANT CELL ARTERITIS (GCA) PATIENTS- DATA FROM THE REAL-LIFE TREATMENT AND SAFETY (REATS)-GCA COHORT
Authors: V. Schönau, G. Corte, S. Ott, K. Tascilar, F. Hartmann, B. Manger, B. Hellmich, A. Pfeil, P. Oelzner, W. A. Schmidt, A. Krause, M. Schmalzing, M. Fröhlich, M. Gernert, N. Venhoff, J. Henes, J. Rech, G. Schett
Journal: Annals of the Rheumatic Diseases (2022)

Background Giant cell arteritis (GCA) has the tendency to relapse once treatment is tapered or stopped. Such relapses represent a potential threat to GCA patients as they can lead to severe symptoms and organ damage. Objectives To assess the frequency and type of relapses in patients with GCA Methods The Real-Life Treatment and Safety (REATS)-GCA cohort has been established by extracting the data on clinical presentation, inflammatory markers, imaging, comorbidities, treatments and serious adverse events of GCA patients from 6 specialized centres in Germany. We undertook descriptive and survival analyses (Kaplan-Meier), and compared baseline characteristics of participants with vs. without relapse. Ethical approval for the cohort was obtained. Results We included 395 patients with a mean age of 71 years, including 264 (66.8 %) females and 129 (32.7%) males. Diagnosis of GCA was supported by temporal artery ultrasound in 37%, 18 F-FDG-PET/CT in 29%, temporal artery biopsy in 14% of patients and by MRI or clinically in the remaining patients. 31% of patients presented with an isolated cranial manifestation and 18% with isolated extracranial manifestations. Most common presenting symptoms were headache (57%), fatigue (55%), weight loss (42%) and polymyalgia (38%) (Table 1). The most common comorbidities at the time of study inclusion were arterial hypertension (68%), followed by osteoporosis (26%). Within a median total follow-up duration of 22.2 (11.7-40.6) months, 97 of the 395 patients relapsed including 15 patients who relapsed more than once. The median (IQR) time to first relapse was 12.5 (7.1-21.8) months. Median relapse-free survival was 7.8 years with a relapse risk of 12% (CI, 9 to 15%) at 1 year and 38% (CI, 30 to 45%) at 5 years (Figure 1). Most common symptoms at relapse were headache (35%), polymyalgia (23%), fatigue (19%) and night sweats (12%) (Table 1). Three patients relapsed with sudden loss of vision. Among the 114 relapses observed, 94 (83%) occurred under prednisolone treatment with a median dose of 7.0 mg/day (IQR 4.0-12.5). 26 (23%) occurred under methotrexate and 14 (12%) under tocilizumab treatment. Comparing the baseline characteristics that were documented in this study, we did not find a statistically significant difference in relapsing versus non-relapsing GCA patients. Table 1. Symptom at disease onset N=395 (%) Symptom at relapse N=97 (%) Headache 216 (54.7) Headache 35 (30.7) Fatigue 208 (52.7) Polymyalgia (PMR) 23 (20.2) Weight loss 159 (40.3) Fatigue 19 (16.7) Polymyalgia (PMR) 144 (36.5) Vision impairment 13 (11.4) Night sweats 140 (35.4) Night sweats 12 (10.5) Headache in the temple area 125 (31.6) Headache in the temple area 12 (10.5) Jaw pain 121 (30.6) Jaw pain 11 (9.6) Vision impairment 118 (29.9) Morning stiffness 7 (6.1) Morning stiffness 89 (22.5) Weight loss 7 (6.1) Fever 80 (20.3) Claudication upper limb 6 (5.3) Swelling temporal arteries 77 (19.5) Arthralgia 6 (5.3) Vision loss 57 (14.4) Claudication lower limb 5 (4.4) Scalp tenderness 38 (9.6) Vision loss 3 (2.6) Claudication upper limb 38 (9.6) Arthritis 3 (2.6) Claudication lower limb 34 (8.6) Scalp tenderness 2 (1.8) Arthralgia 28 (7.1) Fever 2 (1.8) Arthritis 3 (0.8) Swelling temporal arteries 2 (1.8) Figure 1. Conclusion About one fourth of GCA patients relapsed and the overwhelming majority of relapses occurred before patients were able to stop glucocorticoids. The leading symptoms at relapse are headache and fatigue, while loss of vision is rare (0.76%). Baseline characteristics seem to be poorly informative about the risk of relapse, therefore regular monitoring of GCA patients is necessary. Acknowledgements This research was financially supported by Roche Pharma Ag and Chugai Pharma Europe Ltd. Disclosure of Interests Verena Schönau Speakers bureau: Novartis, Janssen, Grant/research support from: Roche, Chugai, Giulia Corte: None declared, Sebastian Ott: None declared, Koray Tascilar: None declared, Fabian Hartmann: None declared, Bernhard Manger: None declared, Bernhard Hellmich: None declared, Alexander Pfeil: None declared, Peter Oelzner: None declared, Wolfgang A. Schmidt: None declared, Andreas Krause: None declared, Marc Schmalzing: None declared, Matthias Fröhlich: None declared, Michael Gernert: None declared, Nils Venhoff: None declared, Jörg Henes: None declared, Jürgen Rech Speakers bureau: Abbvie, Biogen, BMS, Chugai, GSK, Lilly, MSD; Novartis, Roche, Sanofi, Sobi, UCB,, Consultant of: Biogen, BMS, Chugai, GSK, Lilly, MSD, Novartis, Roche, Sanofi, Sobi, UCB, Grant/research support from: Sobi, Novartis, Georg Schett: None declared